Trials / Unknown
UnknownNCT05155215
Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma
A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IM19 CAR-T cells | IM19 CAR-T cells will be administered at dose level: 100×10\^6 CAR-T cells or 200×10\^6 CAR-T cells |
| DRUG | Cyclophosphamide | 300 mg/m\^2 per day for 3 days (IV) |
| DRUG | Fludarabine | 30 mg/m\^2 per day for 3 days (IV) |
Timeline
- Start date
- 2021-12-31
- Primary completion
- 2022-12-31
- Completion
- 2023-02-28
- First posted
- 2021-12-13
- Last updated
- 2021-12-13
Source: ClinicalTrials.gov record NCT05155215. Inclusion in this directory is not an endorsement.